Point-of-care Capillary HbA1c Testing for Type 2 Diabetes Screening Among At-risk Individuals in Rural Dali, China | NCT07718867

NCT07718867

Overview

NCT ID: NCT07718867
Lead Sponsor: The University of Hong KongOTHER
Official Title: Effectiveness and Cost-Effectiveness of Point-of-care Capillary HbA1c Testing for Type 2 Diabetes Screening Among At-risk Individuals in Rural Dali, Yunnan, China: A Cluster Randomised Controlled Trial
Brief Summary: This project aims to compare Point-of-care capillary HbA1c (POC-cHbA1c) testing and fingerstick random blood glucose (RBG) testing in terms of type 2 diabetes detection rate and cost-effectiveness, in order to optimise current screening strategies for rural populations at high risk of diabetes in rural Dali, China, and to improve treatment adherence and self-management among people with diabetes.
Conditions: Type 2 Diabetes
Pre-diabetes
Interventions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Aged 18 years or above;

Permanent residents of Dali City who have lived locally for at least six consecutive months;

Registered as rural residents;

No known history of diabetes;

Meet at least one of the high-risk criteria for T2DM specified in the Chinese Guidelines for the Prevention and Treatment of Diabetes issued by the Chinese Diabetes Society;

Able to understand the study information and provide written informed consent.

Exclusion Criteria:

Known history of T2DM or currently receiving glucose-lowering treatment;

HbA1c testing with a clear result within the past three months, or completion of standardised diabetes screening within the past six months;

Pregnant or breastfeeding at the time of recruitment;

Active thyroid disease or other active endocrine disorders at recruitment, such as Cushing's syndrome or acromegaly;

Known haemoglobinopathy, severe anaemia, recent acute blood loss, or history of blood transfusion or blood donation within the past three months;

Currently receiving treatment that may substantially affect interpretation of HbA1c, such as erythropoietin therapy or recent high-dose iron therapy.